BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 5066105 · Received September 9, 2015

    Report

    Report Number
    2028253-2015-00005
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    September 8, 2015
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN. PHOTOGRAPHS PROVIDED SHOW SEPARATION OF THE SOLE FROM THE SHOE. THE SUPPLIER OF THE POST-OP SHOE HAS BEEN ISSUED A CORRECTIVE ACTION AND HAS BEEN UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE. BREG IS NO LONGER DISTRIBUTING THIS PRODUCT. AWAITING PRODUCT RETURN.

    Description of Event or Problem · 1

    SOLE SEPARATED FROM BASE OF SHOE. PATIENT FELL AND SPRAINED ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595596 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention